Tobacco Documents Online

~ ,o/,~~~ RESEARCH NOTES ` THE LAE fRILE ISSUE WENT TO THE US SUPREME COURT via an FDA certiorari petition seek- ing a hearing on its appeal of a 10th Circuit Court of Appeals in Rutherford v. Kennedy and Califano that injectable laetrile must be made avail- able to MD-certifi=sd terminally ill cancer patients. The circuit court in Denver unanimously found that the terms "safety and effectiveness" in the Food, Drug and Cosmetic Act "have no reasonable application to terminally ill canc=;r patients." The ruling would "make it difficult if not impossible for the commissioner to discharge his statutory responsibility to keep unproven drugs out of the marketplace," FDA argued. Noting th:.t "the FD&C Act contains no exemption from its premarketing clearance re- quirement:; for drugs intended for use by the terminally ill," the agency asserted that the circuit court misconstrued the concepts of safety and efficacy. "Neither term means, as the court evi&ntly assumed, that the drug will cure the affliction for which it is taken," the position stated, explaining that a drug is effective if "substantial evidence" shows it has the effect clahned in labeling and is safe "if its benefits - either therapeutic or palliative - out- weigh any adverse effects of its use." FDA argued "the court of appeals should not have substituted its own judgment conc=rning the desirability of a special standard - that is no standard at all - for drugs for the 'terminally ill' in place of the determination of Congress and the comunissioner that such an exception from the statutory requirements is neither appr--priate nor feasible." -0- AMERICAN SOCIETY OF ANESTHESIOLOGISTS SIGNED A CONSENT agreement with the ~i Federal Trade Com- mission under which the 15,000-member ASA, representing 90% of all anesthesiologists in the US, will drop its ban on membe.s being salaried employees of hospitals. FTC said that for at least the past 10 years the ASA "Guidelines ;:o the Ethical Practice of Anesthesiology" have stated that members should be paid only on a fee-for-serviczs basis and should not practice as salaried employees of organizations. FTC charged the restrictions "have had the effect of depriving consumers of benefits of competition among anesthesiologists." FTC also said the guidelines had the effect of limiting the ability of hospitals to negotiate freely and execute contracts with ASA members and others; influencing the prices which anesthesio ~ogists charge, and restraining, limiting, and foreclosing competition among anes- thesiologists. FTC's proposed order under the agreement would prevent ASA from "impor- tuning or zmgaging in threats or acts of reprisal, coercion, or intimidation with the purpose or effect of restraining or impeding anesthesiologists from practicing anesthesiology other than on a 'ee-for-service basis." -0- ~C-- I t__ ~ D1V. QF {:ANCER CAUSE AND PREVENTION's STORMY DEPUTY DIRECTOR, Gio Gori, on * leave from his Natl. Cancer Institute post after proclaiming some cigarettes achieve "tolerable" risk levels ("The Blue Sheet" Sept. 6, R-14-2), will leave NCI "when it's possible to make the change," his boss. announced Oct. 17. DCCP Director G.egory O'Conor told his new Board of Scientific Counselors Gori intends "to have a posi- tion elsewhere" atter completing a one-year master's program at Hopkins. Loui-; Sibal is "unofficial acting deputy," O'Conor told the BSC. At the same time, Gori is still on the public payroll as a $47,500-a-year supergrade. The new FIW, headed by Peter Magee, Temple, will be asked to conduct peer review of the DCCP intiamural research program, which currently undergoes no such review, O'Conor said. Also, the board will offer "concept clearance" for ideas about research areas the div. wants to encourage through contracts , ~;andfi more often, requests for applicationsT 1069 Z 3 _~.~~ -,, T- [1VIN 0110743 G3-6

RN-2 The Blue Sheet Vol. 21, No. 42 ? O'Connor said thc div. is mulling a new prevention branch under the carcinogenesis extra- mural program, aiid an assoc. director for the carcinogenesis intramural program established under the recent i1CI reorganization. He said he is also awaiting HEW Secty. Califano's deci- sion on the fate o.' the DCCP bioassay program, part of the dept.-wide toxicology testing program the sect;~. is expected to announce soon ("The Blue Sheet" Sept. 20, RN-3). 0 V NIH CAN'T IGNORE ETHICS IN GRANT REVIEW at the study section or advisory council level just because the application was already ap- proved by an Institutional Review Board. NIH Assoc. Director for Extramural Research and Training William Raub recently told the expiring Natl. Commission for the Protection of Human Subjects. "To remove determinations about ethics, as these issues pertain to the review of individual projects, from the purview of the councils and boards seems inconsistent with both their statutory mandatas and good management practice," Raub wrote to commission chairman Kenneth Ryan. ~ is letter was in response to one Ryan sent to NIH last summer concerning a study section's ~ejection, on ethical grounds, of a grant application that had already been approved by Cornell's IRB ("The Blue Sheet" June 14, p. 7). "I agree that, wh=never a grant application raises a significant ethical issue, the NIH review panel involved should take cognizance of the findings of the pertinent IRB and rely heavily on its judgment," Raub noted. "We encourage this practice and plan to intensify our efforts in this regard witlL the objective of eliminating instances of apparent communication failure." But when se ious disagreement persists, the councils have the obligation to make the final decision, or to solicit advice from such bodies as the Ethics Advisory Board, Raub wrote. As the ethics commission ties up loose ends, Ryan is sending polite letters to Secty. Califano urging him to issue regs on psychosurgery (now nearly one year overdue) and compensation of injured researc z subjects. Ryan has also sent a letter to Sen. Kennedy (D-Mass.) urging an exec order "or, perferably, legislation" to assure "the protection of human subjects in all research conduct~_ d or supported by the intelligence community." -0- DEFENSE DEFENSE DEPT, AND VA OFFICIALS told the House Veterans Affairs Medical Facilities Sub- cmte. Oct. 11 studies will begin soon to determine if Agent Orange creates genetic defects, but the officials said preliminary evidence indicates no permanent damage from exposure tc the powerful herbicide. Agent Orange wa:; used as a defoliant during the Vietnam War. It contains the toxic chemi- cal dioxin, which various studies suggest causes cancer, birth defects, genetic changes, liver tumors, spontane:)us abortions, nervous system disorders, and other illnesses. Authorities estimate that froin 1962 to 1970, between 44 mil. and 100 mil. pounds of the herbicide were sprayed on i:hree to five mil. acres of the Vietnamese countryside. Garth Dettinger, Air Force deputy surgeon general, said exposure to dioxin can result in temporary skin 1_sions, nausea, diarrhea, temporary muscular paralysis, fatigue, headaches, backaches, and lack of sex drive, but that research shows patients recover and do not suffer relapses. "There has not been a single death," he said. Philip Mayo, VFW legislative asst.. quoted what he said were Library of Congress estimates that one drop of Jioxin can kill 1.'_00 people. Cipriano Cueto, Nati. Cancer Institute pesti- TIMN 0110744 T 100- 9 Zf , 4